Aldevron’s Collaboration with Ginkgo Bioworks Yields Manufacturing Breakthrough for Vaccinia Capping Enzyme Used for Manufacturing of mRNA Vaccines

PR Newswire

FARGO, N.D. and BOSTON, Aug. 10, 2021 /PRNewswire/ — Aldevron, a leading research to GMP biomanufacturer of plasmid DNA, mRNA, and proteins, and Ginkgo Bioworks, Inc. (“Ginkgo”) today announced a manufacturing breakthrough driven by their strategic partnership. Aldevron has a successful history of manufacturing high-quality components that enable breakthroughs in the emerging field of genetic medicine. Aldevron is currently experiencing a period of rapid growth, including expanding its manufacturing facilities and adding new products to its growing catalog. Ginkgo, which recently announced a business combination with Soaring Eagle Acquisition Corp. (Nasdaq: SRNG), is building the leading platform for cell programming, enabling customers across industries to improve products and manufacturing processes for greater efficiency and sustainability. 

Ginkgo and Aldevron have been working together in a partnership formed earlier this year to optimize production of mRNA vaccine components. The partnership has already resulted in significant breakthrough improvements in manufacturing yield of the vaccinia capping enzyme (VCE), a component that is often required to produce mRNA therapies and vaccines. Aldevron has the exclusive rights to the protocol conditions of the newly developed manufacturing process, which is over 10-times more efficient than the previous process.

“Aldevron’s industry-leading products and services are the foundation for some of the most exciting advances in biological science today,” said Jason Kelly, CEO of Ginkgo Bioworks. “This partnership represents a momentous growth opportunity for Aldevron as it continues to bolster its already expansive portfolio of products, and an exciting milestone for Ginkgo as we continue to expand our capabilities into the pharmaceutical ecosystem. Aldevron has been a great partner with us on improving VCE, which we see as a key ingredient to scaling mRNA production globally.”

“I’m very excited about combining the additive strengths of Ginkgo Bioworks’ development expertise and Aldevron’s manufacturing horsepower to yield an optimized manufacturing method for vaccinia capping enzyme,” said Tom Foti, President of Aldevron’s Protein Business Unit. “Historically this enzyme has been difficult to produce, and we believe this yield breakthrough will accelerate mRNA therapeutic and vaccine development for manufacturing teams around the world.”

About Aldevron
Aldevron is a premier manufacturing partner in the global genetic medicine field. Founded in 1998 by Michael Chambers and John Ballantyne, the company provides critical nucleic acids and proteins used to make gene and cell therapies, DNA and RNA vaccines, and gene editing technologies. Aldevron’s 700+ employees support thousands of scientists who are developing revolutionary treatments for millions of people.

Media Contact for Aldevron:

Ellen Shafer

Senior Director of Marketing and Communications
[email protected] 
701.297.9256

About Ginkgo Bioworks
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company’s platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo is also actively supporting a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. In May 2021, Ginkgo announced a business combination with Soaring Eagle Acquisition Corp. (Nasdaq: SRNG), which, if completed, will result in Ginkgo, through a parent entity, Ginkgo Bioworks Holdings, Inc., becoming a public company. The transaction is expected to close in the third quarter of 2021, subject to regulatory and shareholder approvals, and other customary closing conditions. For more information, visit www.ginkgobioworks.com.

MEDIA CONTACT:

[email protected]

INVESTOR CONTACT:

[email protected]

ADDITIONAL LEGAL INFORMATION

Forward-Looking Statements Legend

This document contains certain forward-looking statements within the meaning of the federal securities laws with respect to the proposed transaction between Ginkgo and Soaring Eagle Acquisition Corp. (“SRNG”), including statements regarding the benefits of the transaction, the anticipated timing of the transaction, the services offered by Ginkgo and the markets in which it operates, and Ginkgo’s projected future results. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of SRNG’s securities, (ii) the risk that the transaction may not be completed by SRNG’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by SRNG, (iii) the failure to satisfy the conditions to the consummation of the transaction, including the adoption of the agreement and plan of merger by the shareholders of SRNG and Ginkgo, the satisfaction of the minimum trust account amount following redemptions by SRNG’s public shareholders and the receipt of certain governmental and regulatory approvals, (iv) the lack of a third party valuation in determining whether or not to pursue the proposed transaction, (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the agreement and plan of merger, (vi) the effect of the announcement or pendency of the transaction on Ginkgo business relationships, performance, and business generally, (vii) risks that the proposed transaction disrupts current plans of Ginkgo and potential difficulties in Ginkgo employee retention as a result of the proposed transaction, (viii) the outcome of any legal proceedings that may be instituted against Ginkgo or against SRNG related to the agreement and plan of merger or the proposed transaction, (ix) the ability to maintain the listing of SRNG’s securities on Nasdaq, (x) volatility in the price of SRNG’s securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo’s business and changes in the combined capital structure, (xi) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities, and (xii) the risk of downturns in demand for products using synthetic biology. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of SRNG’s proxy statement/prospectus relating to the transaction, and in SRNG’s other filings with the Securities and Exchange Commission (the “SEC”). SRNG and Ginkgo caution that the foregoing list of factors is not exclusive. SRNG and Ginkgo caution readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Neither SRNG nor Ginkgo undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Additional Information and Where to Find It

This document relates to a proposed transaction between Ginkgo and SRNG. This document does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. In connection with the proposed transaction, SRNG filed a registration statement on Form S-4/A with the SEC on August 3, 2021, which included a proxy statement of SRNG and a prospectus of SRNG. The definitive proxy statement/prospectus will be sent to all SRNG shareholders as of the record date to be established for voting on the proposed business combination and Ginkgo stockholders. SRNG also will file other documents regarding the proposed transaction with the SEC. Before making any voting decision, investors and security holders of SRNG and Ginkgo are urged to read the registration statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction.

Investors and security holders may obtain free copies of the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by SRNG through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by SRNG may be obtained free of charge by written request to SRNG at 955 Fifth Avenue, New York, NY, 10075, Attention: Eli Baker, Chief Financial Officer, (310) 209-7280.

Participants in Solicitation

SRNG’s and Ginkgo and their respective directors and officers may be deemed to be participants in the solicitation of proxies from SRNG’s stockholders in connection with the proposed transaction. Information about SRNG’s directors and executive officers and their ownership of SRNG’s securities is set forth in SRNG’s filings with the SEC. To the extent that holdings of SRNG’s securities have changed since the amounts printed in SRNG’s proxy statement, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the proxy statement/prospectus regarding the proposed transaction when it becomes available. You may obtain free copies of these documents as described in the preceding paragraph.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/aldevrons-collaboration-with-ginkgo-bioworks-yields-manufacturing-breakthrough-for-vaccinia-capping-enzyme-used-for-manufacturing-of-mrna-vaccines-301351786.html

SOURCE Ginkgo Bioworks

iSpecimen Reports Second Quarter 2021 Financial Results

-Delivered Revenue Growth of 93% Year-Over-Year-

-Successfully Completed IPO Raising Total Gross Proceeds of $20.7 Million-

PR Newswire

LEXINGTON, Mass., Aug. 10, 2021 /PRNewswire/ — iSpecimen Inc. (Nasdaq: ISPC) (“iSpecimen” or the “Company”), an online marketplace for human biospecimens, today reported its financial results for the three-month period ended June 30, 2021.

“During the second quarter of 2021, iSpecimen successfully completed its initial public offering and began trading on the Nasdaq Capital Market. This is both a significant milestone and the starting point of a new and exciting chapter for the Company,” said Christopher Ianelli, MD, PhD, CEO and President of iSpecimen. “During the quarter, we continued to deliver exceptional financial and operating performance, posted revenue growth of 93% on a year-over-year basis and increased the number of registered research users on the iSpecimen Marketplace™ by 40% year-over-year to more than 3,800 users. With our enhanced capital position, iSpecimen is well-positioned to expand and scale its operations, with the goal of becoming the preeminent, online marketplace for human biospecimens.”

“We continue to broaden our supply network and data assets while improving our technology platform, which should accelerate our sales and revenue momentum as more suppliers and customers embrace the iSpecimen Marketplace. Through our continued expansion, iSpecimen is disrupting the biospecimen procurement process, providing instant access to a vast repository of biospecimens and patient data from a global network of healthcare organizations, thereby empowering researchers to advance scientific discovery,” concluded Dr. Ianelli. 

Q2 2021 Financial & Operational Updates

  • Revenue increased 93% to $2.9 million for the second quarter of 2021, compared to $1.5 million for the same period in 2020.
  • Cash and cash equivalents were $13.2 million as of June 30, 2021.
  • Unique supplier organizations under agreement were 190 as of June 30, 2021, an increase of 33 organizations year-over-year.
  • Unique customer organizations with purchases totaled 378 as of June 30, 2021, an increase of 74 new customer organizations year-over-year.
  • iSpecimen Marketplace had surpassed 3,800 registered research users as of June 30, 2021, up 40% year-over-year.
  • As of June 30, 2021, iSpecimen’s received $8.8 million in purchase orders in 2021, up 31% year-over-year.

Recent Corporate Updates

  • Closed its initial public offering (“IPO”) of 2,250,000 shares of common stock at a public offering price of $8.00 per share on June 21, 2021, for aggregate proceeds of $18 million. On July 1, 2021, the Company sold an additional 337,500 shares of its common stock, pursuant to the underwriters’ full exercise of the overallotment option, at a public offering price of $8.00 per share, for aggregate gross proceeds of $2.7 million. In total, the Company received approximately $18.2 million in net proceeds, after deducting for all underwriting discounts of approximately $1.9 million and other offering costs of approximately $0.6 million. In conjunction with its IPO, the Company began trading on the Nasdaq Capital Market under the ticker symbol “ISPC” on June 17, 2021.
  • In connection with the IPO, the Company eliminated approximately $29.0 million of liabilities and mezzanine classifications from the balance sheet, resulting in $3.0 million of bridge debt remaining outstanding.
  • Enhanced the Board of Directors with the appointments of John Brooks and Margaret Lawrence.
    • Mr. John Brooks currently serves as Managing Director of Healthcare Capital LLC, an investment company that advises early-stage life sciences companies.
    • Ms. Margaret Lawrence currently serves as a General Manager of Wayfair Professional, one of the world’s largest online destinations for home goods.

Financial Results for the Second Quarter of 2021

Revenue for the second quarter of 2021 increased 93% to approximately $2.9 million, compared to approximately $1.5 million for the same period in 2020. The 93% year-over-year increase was primarily due to the success of iSpecimen’s maturing sales team, continued demand for specimens from patients with known COVID-19 test results, and an increasing demand for specimens in non-COVID-19 research areas.

Cost of revenue was approximately $1.5 million for the second quarter of 2021, compared to approximately $0.5 million for the second quarter of 2020. This increase was attributable to an 8% increase in the number of specimens accessioned as well as a 191% increase in the average cost per specimen due to the specimen mix during the second quarter of 2021, compared to the prior year period. In addition to the increase in the average cost per specimen in 2021 being related to specimen mix, a significant project in 2020, which yielded a sizably lower than average cost per specimen, significantly impacted the magnitude of the year over year difference in the average cost per specimen.

General and administrative expenses were approximately $1.5 million for the second quarter of 2021, compared to approximately $0.3 million for the second quarter 2020. The increase was primarily attributable to an increase in costs related to becoming a public company including an increase in legal and accounting expenses, an increase of other general and administrative expenses across the board related to amortization of internally developed software, associated software licenses, human resource related expenses, insurance costs and facility expenses, an increase in director and officer insurance, and an increase in payroll related costs for the chief financial officer. Additionally, the remaining increase is related to costs not expected to recur in the future, such as payroll expenses of approximately $0.5 million for a special IPO bonus provided to all employees and increased legal, accounting and consulting expenses of approximately $0.3 million that did not qualify as offering costs.

Net loss was approximately $1.4 million for the second quarter of 2021, compared to approximately $0.2 million for the same period in 2020. This was primarily due to higher operating expenses partially offset by an increase in revenue, all associated with the factors mentioned above.

Cash was approximately $13.2 million as of June 30, 2021.

Conference Call and Webcast Information

The Company will host a conference call and audio webcast today, Tuesday, August 10th at 8:30 a.m. Eastern Time featuring remarks by Christopher Ianelli, MD, PhD, CEO and President, Tracy Curley, CFO and Treasurer, and Jill Mullan, COO and Secretary.


Event:

iSpecimen Second Quarter 2021 Results Conference Call


Date:

Tuesday, August 10, 2021


Time:

8:30 a.m. Eastern Time


Live Call:

+1-877-425-9470 (Toll Free) or + 1-201-389-0878 (International)


Webcast:


http://public.viavid.com/index.php?id=145777

For interested individuals unable to join the conference call, a replay will be available through August 24, 2021, at +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International). Participants must use the following code to access the replay of the call: 13721607. An archived version of the webcast will also be available on iSpecimen’s Investor Relations site: https://ispecimen.irpass.com/.

About iSpecimen
iSpecimen offers an online marketplace for human biospecimens, connecting life scientists in commercial and non-profit organizations with healthcare providers that have access to patients and specimens needed for medical discovery. Proprietary, cloud-based technology enables scientists to intuitively search for specimens and patients across a federated partner network of hospitals, labs, biobanks, blood centers, and other healthcare organizations. For more information about iSpecimen, please visit www.ispecimen.com.

Forward Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information.

Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to the risks factors contained in the Company’s filings with the Securities and Exchange Commission, which are available for review at www.sec.gov. Forward-looking statements speak only as of the date they are made. New risks and uncertainties arise over time, and it is not possible for the Company to predict those events or how they may affect the Company. If a change to the events and circumstances reflected in the Company’s forward-looking statements occurs, the Company’s business, financial condition and operating results may vary materially from those expressed in the Company’s forward-looking statements.

Readers are cautioned not to put undue reliance on forward-looking statements, and the Company assumes no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information, please contact:

Investor Contact
KCSA Strategic Communications
Allison Soss / Scott Eckstein
[email protected]

Media Contact

Kaitlynn Cooney

For iSpecimen
[email protected]
617.587.2811

 


iSpecimen Inc.


Condensed Balance Sheets


June 30, 2021


December 31, 2020


ASSETS


(Unaudited)

Current assets:

Cash

$

13,184,310

$

695,909

Accounts receivable – unbilled

1,125,789

652,761

Accounts receivable, net of allowance for doubtful accounts of $147,714 and $108,096 at June 30, 2021 and December 31, 2020, respectively

1,987,112

1,526,392

Prepaid expenses and other current assets

442,089

417,929

Tax credit receivable, current portion

179,376

179,376

Total current assets

16,918,676

3,472,367

Property and equipment, net

55,879

75,589

Internally developed software, net

2,602,886

2,634,139

Security deposits

27,601

27,601

Total assets

$

19,605,042

$

6,209,696


LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

Current liabilities:

Accounts payable

$

3,233,231

$

1,792,432

Accrued expenses

1,879,812

810,910

Accrued interest

9,864

3,696,944

Convertible notes payable, related parties, net of unamortized debt discount and debt issuance costs

5,490,811

Derivative liability for embedded conversion features on convertible notes payable

2,373,000

Bridge notes payable, net of debt issuance costs

4,589,228

Bridge notes payable, related parties

1,905,000

Derivative liability for embedded conversion feature on bridge notes payable and bridge notes, related parties

Note payable, current portion

604,109

Deferred revenue

802,860

873,254

Total current liabilities

5,925,767

22,135,688

Note payable, net of current portion

178,899

Bridge notes payable, net of debt issuance costs

2,675,000

Bridge notes payable, related parties

325,000

Total liabilities

8,925,767

22,314,587

Commitments and contingencies

Series B convertible preferred stock, $0.0001 par value, 3,200,000 shares authorized, 0 and 572,465 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

7,999,997

Series A-1 convertible preferred stock, $0.0001 par value, 556,550 shares authorized, 0 and 100,365 issued and outstanding at June 30, 2021 and December 31, 2020, respectively

561,041

Series A convertible preferred stock, $0.0001 par value, 3,427,871 shares authorized, 0 and 618,182 issued and outstanding at June 30, 2021 and December 31, 2020, respectively

2,612,038

Total convertible preferred stock

11,173,076

Stockholders’ equity (deficit)

Common stock, $0.0001 par value, 200,000,000 shares authorized, 6,596,729 issued, and 6,565,729 outstanding at June 30, 2021, and 16,000,000 shares authorized, 967,213 issued and 936,213 outstanding at December 31, 2020

657

94

Additional paid-in capital

45,094,782

1,779,698

Treasury stock, 31,000 shares at June 30, 2021 and December 31, 2020, at cost

(172)

(172)

Accumulated deficit

(34,415,992)

(29,057,587)

Total stockholders’ equity (deficit)

10,679,275

(27,277,967)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

$

19,605,042

$

6,209,696

 

 


iSpecimen Inc.


Condensed Statements of Operations 


(Unaudited)


Three months ended June 30,


Six months ended June 30,


2021


2020


2021


2020

Revenue

$

2,903,876

$

1,504,569

$

5,867,683

$

3,216,228

Operating expenses:

Cost of revenue

1,489,196

473,982

3,112,847

1,128,249

Technology

361,799

291,601

771,750

718,314

Sales and marketing

647,592

367,617

1,176,978

799,256

Supply development

100,693

147,588

212,269

262,193

Fulfillment

287,275

185,185

556,371

400,355

General and administrative

1,545,852

343,602

2,508,643

656,855

Total operating expenses

4,432,407

1,809,575

8,338,858

3,965,222

Loss from operations

(1,528,531)

(305,006)

(2,471,175)

(748,994)

Other income (expense), net

Interest expense

(1,133,479)

(459,005)

(1,986,407)

(1,048,220)

Change in fair value of derivative liability on convertible notes

(117,000)

583,000

(271,000)

(22,000)

Change in fair value of derivative liability on bridge notes and bridge notes, related parties

1,630,700

1,582,700

Gain (loss) on extinguishment of bridge notes and bridge notes, related parties

9,746

(2,740,425)

Loss on extinguishment of convertible notes and convertible notes, related parties

(260,185)

(260,185)

Gain on extinguishment of note payable

788,156

Other income (expense)

3,663

6,688

(69)

6,691

Interest income

172

86

309

Other income (expense), net

133,617

130,769

(2,887,230)

(1,063,220)

Net loss before benefit from income taxes

(1,394,914)

(174,237)

(5,358,405)

(1,812,214)

Benefit from income taxes

145

145

Net loss

$

(1,394,914)

$

(174,092)

$

(5,358,405)

$

(1,812,069)

Net loss per share

    Basic and diluted

$

(0.87)

$

(0.19)

$

(4.21)

$

(1.94)

Weighted average common shares outstanding

    Basic and diluted

1,611,774

936,213

1,273,993

936,213

 

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ispecimen-reports-second-quarter-2021-financial-results-301351561.html

SOURCE iSpecimen Inc.

More Than 70% of Parents Say Unvaccinated Kids Should Wear Masks at School According to a ValuePenguin.com Survey

Another 56% of parents say their school-aged children will attend in-person school this fall.

PR Newswire

NEW YORK, Aug. 10, 2021 /PRNewswire/ — As the debate around mask policies for children heading back to school continues to heat up, and a strong desire from many parents to get kids back to in-person learning full time, the question of whether children should wear masks at school is becoming more complicated than ever.

ValuePenguin surveyed more than 1,000 parents with children under 18 to learn more about where parents stood on masks and vaccinations when it comes to heading back to school. 

Key findings:

  • 74% of parents with kids younger than 18 support masks for students who haven’t gotten the COVID-19 vaccination. Parents in the Northeast are most supportive (85%), while those in the South are least supportive (67%).
  • 44% of parents whose children will attend school in person at least part of the time plan to require their unvaccinated kids to wear masks, and a further 31% will ask their vaccinated kids to mask up. However, 25% won’t require their children to wear masks at school regardless of their vaccination status.
  • As the delta variant surges, 44% of parents say their kids won’t go to in-person school full time this fall. That percentage breaks down to 27% opting for a hybrid schedule and 11% for full-time virtual school, as well as 6% who aren’t sure what to do yet.
  • On the other hand, 12% of parents changed their child’s school during the pandemic so they could learn in person. Additionally, 32% of parents whose children will attend school in person this fall say their child’s learning suffered at home.
  • Though COVID-19 vaccines have been approved for children 12 and older, 31% of parents aren’t comfortable allowing their age-eligible children to get the vaccine. That percentage jumps to 39% among mothers, compared with 21% among fathers.

View full report: https://www.valuepenguin.com/masks-at-school-survey

About ValuePenguin.com: ValuePenguin.com, part of LendingTree (NASDAQ: TREE), is a personal finance website that conducts in-depth research and provides objective analysis to help guide consumers to the best financial decisions. ValuePenguin focuses on value, assessing whether the return of a particular decision is worth the cost or risk of that option, and how this stacks up with the other possible choices they may have. For more information, please visit www.valuepenguin.com, like our Facebook page, or follow us on Twitter @ValuePenguin.

Media Contact:
Nadia Gonzalez (Mrs.)
[email protected]

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/more-than-70-of-parents-say-unvaccinated-kids-should-wear-masks-at-school-according-to-a-valuepenguincom-survey-301351740.html

SOURCE ValuePenguin.com

CASI Pharmaceuticals To Report Second Quarter 2021 Financial Results And Host Conference Call August 12, 2021

PR Newswire

ROCKVILLE, Md. and BEIJING, Aug. 10, 2021 /PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the Company will host a conference call reviewing the second quarter highlights at 8:00 a.m. ET on Thursday, August 12th, 2021.

On the call, CASI’s Chairman & CEO will provide an update on the Company’s business and upcoming milestones. The conference call can be accessed by dialing (833) 420-0382 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), 58086567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 5639775. Participants dialing in via International Toll-Free Service (ITFS) numbers will be required to provide the following passcode to join the conference call: 8336474459, 6025859887.

This call will be recorded and available for replay by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and enter 5639775 to access the replay.

About CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company’s China-based regulatory and commercial competencies and its global drug development expertise. The Company’s operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., which is located in Beijing, China. The Company has built a commercial team of more than 80 hematology and oncology sales and marketing specialists based in China. More information on CASI is available at www.casipharmaceuticals.com.


COMPANY CONTACT:


CASI Pharmaceuticals, Inc.

240.864.2643



[email protected]


INVESTOR CONTACT:


Solebury Trout

Bob Ai

646.378.2929


[email protected]

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-report-second-quarter-2021-financial-results-and-host-conference-call-august-12-2021-301351836.html

SOURCE CASI Pharmaceuticals, Inc.

Innoviz Technologies Partners with Leading Autonomous System Provider Curium to Enable a Safe Vehicle Calibration Experience in Southeast Asia

Through the integration and distribution of Innoviz’s Products, Curium intends to enhance their advanced driving system

PR Newswire

TEL AVIV, Israel and SINGAPORE, Aug. 10, 2021 /PRNewswire/ — Innoviz Technologies (Nasdaq: INVZ), a leading provider of high-performance, solid-state LiDAR sensors and perception software, has formed a partnership with Curium, a leading developer of automated calibration services for Autonomous Systems.

Curium’s automated calibration software ensures that the vehicle’s sensor suite is working as it should, even under dynamically changing conditions. This is a critical problem to solve, as sensors which are out of adjustment can lead to mis-detections and accidents.

Through the partnership agreement, Curium will apply its patented calibration techniques to its advanced driving system using the advanced capabilities of Innoviz’s solid-state LiDAR sensor. Curium’s solution actually simplifies the integration of the InnovizOne Lidar into any vehicle, as well as the installation of the sensor in the production stage.

Curium will also distribute and promote Innoviz’s products throughout Southeast Asia across multiple sectors, including automotive original equipment manufacturers (OEMs), shuttles, robotaxis, and various industrial applications. The partnership between the companies builds on Innoviz’s strong relationships in Asia, including Korea, Japan, and China.

“We are pleased to partner with Innoviz Technologies, a company that has by far the best LiDAR on the market,” said Dr. Ali Hasnain, CEO and founder of Curium. “With Innoviz’s market-leading LiDAR solution and Curium’s ability to perform multi-sensor Continuous Dynamic Calibration, we will be giving both companies a distinct market advantage when it comes to systems that require the best in LiDAR technology with superior levels of reliability. Innoviz’s strong global presence will enable us to work together in Asia and beyond, giving us confidence in a long and fruitful collaboration.”

About Innoviz Technologies

Innoviz is a leading provider of technology that will put autonomous vehicles on roads. Innoviz’s LiDAR technology can “see” better than a human driver and meets the automotive industry’s strict expectations for performance, safety, and price. Selected by BMW for its fully autonomous car program, Innoviz’s technology will be deployed in BMW’s consumer vehicles. Innoviz is backed by top-tier strategic partners and investors, including SoftBank Ventures Asia, Samsung, Magna International, Aptiv, Magma Venture Partners, and others. For more information, visit www.innoviz.tech.

About Curium

Curium is a market leading innovator in sensor calibration technologies with a patent pending solution for multi-sensor calibration. This approach to calibration ensures that development of autonomous systems such as Autonomous Vehicles can be rapidly escalated to level 4 and 5 of automation. This is done by Curium’s ability to perform Continuous Dynamic Calibration (CDC) across multiple sensor types such as LiDAR, Radar and Cameras, ensure complete confidence in the accuracy and reliability of the sensor data and therefore enabling AI modules to make accurate decisions all the time, every time. For more information, visit www.curium.sg.

Join the discussion:
Facebook, LinkedIn, YouTube, Twitter

Photo – https://mma.prnewswire.com/media/1591695/Innoviz_Technologies.jpg
Logo – https://mma.prnewswire.com/media/1496323/Innoviz_Technologies_Logo.jpg

Innoviz Technologies

Contact Information

[email protected]

Investor Contact

Maya Lustig

Innoviz Technologies
+972 54 677 8100
[email protected]

Gateway Investor Relations
Cody Slach or Matt Glover
+1 (949) 574-3860 
[email protected]

Curium

[email protected]


Forward Looking Statements

This announcement contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the services offered by Innoviz, the anticipated technological capability of Innoviz’s products, the markets in which Innoviz operates and Innoviz’s projected future results. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this announcement, including but not limited to, the ability to implement business plans, forecasts, and other expectations, the ability to identify and realize additional opportunities, and potential changes and developments in the highly competitive LiDAR technology and related industries. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in Innoviz’s annual report on Form 20-F filed with the SEC on April 21, 2021 and other documents filed by Innoviz from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Innoviz assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Innoviz gives no assurance that it will achieve its expectations.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/innoviz-technologies-partners-with-leading-autonomous-system-provider-curium-to-enable-a-safe-vehicle-calibration-experience-in-southeast-asia-301351944.html

SOURCE Innoviz Technologies

Phoenix New Media to Announce Second Quarter 2021 Financial Results on Monday, August 16, 2021

PR Newswire

BEIJING, Aug. 10, 2021 /PRNewswire/ — Phoenix New Media Limited (“Phoenix New Media”, “ifeng” or the “Company”) (NYSE: FENG), a leading new media company in China, today announced that it will report its second quarter 2021 financial results on Monday, August 16, 2021 after the market closes. The earnings release will be available on ifeng’s investor relations website at http://ir.ifeng.com.

Following the earnings release, ifeng’s management team will hold a conference call on Monday, August 16, 2021 at 9:00 p.m. Eastern Time (or Tuesday, August 17, 2021 at 9:00 a.m.Beijing/Hong Kong time) to discuss the financial results and operating performance.

Due to the outbreak of COVID-19, operator assisted conference calls are not available at the moment. All participants must preregister online prior to the call to receive the dial-in numbers. Preregistration may require a few minutes to complete.

Conference Call Preregistration

Participants can register for the conference call by navigating to http://apac.directeventreg.com/registration/event/7091964. Once preregistration has been complete, participants will receive dial-in numbers, Direct Event Passcode, and registrant ID by email.

Please dial in 10 minutes prior to the call, using the participant dial-in numbers, Direct Event Passcode and unique registrant ID which would be provided upon registering. You will be automatically linked to the live call after completion of this process.

A replay of the call will be available through August 25, 2021 by dialing the following numbers:

International:                           +61 2 8199 0299
Mainland China:                      4006322162
Hong Kong:                             +852 30512780
United States:                          +1 646 254 3697
Conference ID:                        7091964

A live and archived webcast of the conference call will also be available on the Company’s investor relations website at http://ir.ifeng.com.

About Phoenix New Media
Limited

Phoenix New Media Limited (NYSE: FENG) is a leading new media company providing premium content on an integrated Internet platform, including PC and mobile, in China. Having originated from a leading global Chinese language TV network based in Hong Kong, Phoenix TV, the Company enables consumers to access professional news and other quality information and share user-generated content on the Internet through their PCs and mobile devices. Phoenix New Media’s platform includes its PC channel, consisting of ifeng.com website, which comprises interest-based verticals and interactive services; its mobile channel, consisting of mobile news applications, mobile video application and mobile Internet website; and its operations with the telecom operators that provides mobile value-added services.

For investor and media inquiries please contact

Phoenix New Media Limited
Qing Liu
Email: [email protected]

ICR, Inc.
Robin Yang
Tel: +1 (646) 405-4883
Email: [email protected]

Cision View original content:https://www.prnewswire.com/news-releases/phoenix-new-media-to-announce-second-quarter-2021-financial-results-on-monday-august-16-2021-301351863.html

SOURCE Phoenix New Media Limited

Altair Acquires S-FRAME Software, Powerful Structural Analysis and Design Software, to Strengthen and Accelerate Global Footprint in Architecture, Engineering, and Construction (AEC)

PR Newswire

As an innovator in AEC structural simulation and certification for 40 years, S-FRAME Software is a leading advocate for the use of timber in building design

TROY, Mich., Aug. 10, 2021 /PRNewswire/ — Altair (Nasdaq: ALTR), the global leader converging simulation, HPC, and AI, today announced that it has acquired S-FRAME Software, a structural analysis software platform used by engineers to evaluate a structure’s ability to withstand external loads (like wind, water, and snow) and meet design code requirements around the world.

For more 30 years, high-end architectural clients have utilized Altair’s sophisticated technology – which is also used to design high-tech modern aircraft and automobiles – to develop some of the world’s most innovative and iconic structures. Utilizing S-FRAME Software’s finite element structural analysis and code support with Altair’s high-fidelity structural optimization solutions will allow architects and civil engineers to be more innovative and bring their visions to life while adhering to local code requirements.

According to CIMdata, the leader in product lifecycle (PLM) education and research, “the AEC segment will be one of the fastest-growing segments of the PLM market with a 14.7 percent CAGR to $11 billion in 2025.”

“We are excited to expand our presence in the rapidly growing AEC market to lead the transformation from rule-based design to predictive, high-performance design, fueled by simulation,” said James R. Scapa, founder and chief executive officer, Altair. “By using highly sophisticated performance-based, predictive simulation, architects and designers will be able to be more creative, fueling innovation while increasing safety.”

As an AEC innovator for many years, S-FRAME Software’s integrated solutions make it possible to analyze, design, and detail structures regardless of geometric complexity, loading conditions, nonlinear effects, design code requirements, or material type including steel, concrete, composites, or mass timber, one of the hottest in sustainable building materials. S-FRAME Software has been a leading advocate for the use of timber in building design as the material offers sustainability through greenhouse gas reduction and other environmental benefits like insulation as well as architectural aesthetics. S-FRAME Software also allows users to produce comprehensive and detailed design reports that include clause references and intermediate results for multiple design code support.

“Joining the Altair team is a strategic way to accelerate our growth and become part of a full solutions suite with their advanced structural design offerings,” said Marinos Stylianou, chief executive officer, S-FRAME Software. “We are confident our combined offerings will be able to empower engineers, designers, and builders to reach new heights.”

Founded in 1981, S-FRAME Software is based in British Columbia, Canada and serves a global client base.

S-FRAME Software will be available via Altair Units, Altair’s patented, subscription-based licensing model, which allows organizations to pay only for what their employees need, when they need it.

About Altair (Nasdaq: ALTR)

Altair is a global technology company that provides software and cloud solutions in the areas of simulation, high-performance computing (HPC), and artificial intelligence (AI). Altair enables organizations across broad industry segments to compete more effectively in a connected world while creating a more sustainable future. To learn more, please visit www.altair.com.

Media Contacts

Corporate

Jennifer Ristic

+1.216.849.3109
[email protected]

Altair Europe/The Middle East/Africa

Evelyn Gebhardt

+49 7031 6208 0
[email protected]

Investor Relations

The Blueshirt Group
Monica Gould +1 212.871.3927
[email protected]

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/altair-acquires-s-frame-software-powerful-structural-analysis-and-design-software-to-strengthen-and-accelerate-global-footprint-in-architecture-engineering-and-construction-aec-301351474.html

SOURCE Altair

Kaixin Auto Holdings Announces Plans for Smaller Size Electric Vehicles

BEIJING, Aug. 10, 2021 (GLOBE NEWSWIRE) — Kaixin Auto Holdings (“Kaixin” or the “Company”) (NASDAQ: KXIN) today announced plans to enter the smaller size electric vehicle (EV) market in China. Kaixin’s new energy vehicle unit has launched development plans focused on smaller EV models in the subcompact and minicompact categories. To speed up the process, the Company has discussed mergers and acquisitions with a number of electric car manufacturers. Kaixin will disclose the results in a timely manner.

Automobiles have been gradually shifting from a symbol of wealth and social status to the fundamental role of transportation tool in China. The rapid development of electric vehicle technology has closed in the technological gap to fuel vehicles and substantially lowered production costs, which has led to more consumption of electric vehicles. In addition, the rise of the younger generation of consumers in Chinese cities, who carry a preference for vehicles of lighter weight and smaller size, has made smaller size electric cars a dark horse in the Chinese automobile market segmentation. Sales of subcompact and minicompact electric cars are forecasted to reach 5 million units in 2025, making it one of the best-selling models in Chinese auto market.


About Kaixin Auto Holdings

Kaixin Auto Holdings is one of the primary dealership networks in the premium used car segment and new car sales in China. Supported by the rapid growth of China’s used car market and leveraging its own hybrid business model that offers both strong online and offline presence, Kaixin has transformed from a tech-enabled financing platform into a nationwide dealer network that combines its own and affiliated dealers as well as value-added services.


Safe Harbor Statement

This announcement may contain forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the business outlook for 2021 and quotations from management in this announcement, as well as Kaixin’s strategic and operational plans, contain forward-looking statements. Kaixin may also make written or oral forward-looking statements in its filings with the U.S. Securities and Exchange Commission (“SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Kaixin’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: our goals and strategies; our future business development, financial condition and results of operations; the expected growth of the social networking site market in China; our expectations regarding demand for and market acceptance of our services; our expectations regarding the retention and strengthening of our relationships with used auto dealerships; our plans to enhance user experience, infrastructure and service offerings; competition in our industry in China; and relevant government policies and regulations relating to our industry. Further information regarding these and other risks is included in our other documents filed with the SEC. All information provided in this press release and in the attachments is as of the date of this press release, and Kaixin does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

For more information, please contact:

Kaixin Auto Holdings

Investor Relations

Email: [email protected] 

SOURCE: Kaixin Auto Holdings



InspireMD Announces Strong Second Quarter 2021 Financial Results


Revenue rebound, strong procedural recovery


Management to host investor conference call today, August 10, 2021, at



8:30am ET

TEL AVIV, Israel, Aug. 10, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced financial and operating results as of and for the second quarter ended June 30, 2021.

Second Quarter 2021 and recent highlights

  • Revenue of $1,038,000, an increase of 231.6% compared to the same period in 2020
  • Initiated U.S. enrollment in the “C-Guardians” IDE clinical trial. Eleven (11) patients treated and enrolled in the first 2 weeks at Ballad Health Systems (Kingsport, TN) by Principal Investigator Dr. Christopher Metzger
  • Transferred the listing of the company’s common stock and warrants to the Nasdaq Capital Market for access to broader and more fundamental investor base
  • Appointed seasoned marketing executive Kathryn Arnold to the company’s Board of Directors
  • Appointed acclaimed interventional cardiologist Kenneth Rosenfield, M.D. as Chair of the company’s newly formed Medical Advisory Board (MAB)

Marvin Slosman, InspireMD CEO, commented, “We are pleased with our second quarter results that showed strong procedural recovery and market demand of CGuard EPS. Our ultimate goal is to change the standard of care in the treatment of carotid artery disease away from surgical endarterectomy to the minimally invasive use of CGuard EPS Carotid Stent System.

“Our commercial efforts in driving global expansion, through expanding use of CGuard EPS in our 33 served markets, combined with growing our footprint into the U.S. and Asia, has created awareness of the clinical advantages of CGuard EPS. Initiating our U.S. Food and Drug Administration (FDA) C-Guardians IDE trial this quarter marked a milestone for the company in establishing awareness and experience with CGuard EPS among U.S. physicians treating carotid artery disease. To date, Interventional Cardiologist Chris Metzger, M.D., our principal investigator, and system chair of clinical research at Ballad Health System (Kingsport, TN) has already enrolled 11 patients in the trial in the first two weeks.

“During the second quarter, we successfully transferred the listing of our shares and warrants to the Nasdaq Capital Market, which we believe will help broaden our shareholder base and increase interest by institutional and fundamental investors to create additional long-term shareholder value.

“Additionally, we appointed seasoned MedTech marketing executive Kathryn Arnold to our Board of Directors. Ms. Arnold brings more than two decades of strategy and commercialization experience in the medical device industry. Her knowledge and leadership will be invaluable in helping the company shape our strategic planning and expanding our commercial and business development.

“We also formed a Medical Advisory Board composed of global Key Opinion Leaders (KOL’s) who treat carotid artery disease to provide the company guidance and direction on clinical strategy, product pipeline, and technology advancements. To lead this Board, we have appointed acclaimed interventional cardiologist, Kenneth Rosenfield, M.D. as Chair. Dr. Rosenfield is the Section Head for Vascular Medicine and Intervention and chairs the Acute Myocardial Infarction (STEMI) Committee for the Cardiac Catheterization Laboratory at Massachusetts General Hospital.

“We continue to advance our global growth plans in our Asian markets. In China we are progressing with our distributor partners to initiate our regulatory trial toward market approval, and we continue our commercial expansion efforts into the markets of Japan, Taiwan and South Korea.

“We are making significant progress advancing our product pipeline with new innovation and offerings. CGuard Prime, our next generation trans-femoral delivery system is scheduled for regulatory submission in early 2022 with commercial launch in the second half 2022. Additionally, we are making great progress on a new embolic protection device (EPD) and delivery system, expanding our toolset and offerings to the vascular surgical community,” concluded Mr. Slosman.

Financial Results for the Second Quarter ended June 30, 2021

For the three months ended June 30, 2021, revenue increased by $725,000, or 231.6%, to $1,038,000, from $313,000 during the three months ended June 30, 2020. This increase was predominantly driven by a 276.0% increase in sales volume of CGuard EPS from $271,000 during the three months ended June 30, 2020, to $1,019,000 during the three months ended June 30, 2021. This sales increase was mainly due to the fact that in the three months ended June 30, 2021, procedures with CGuard EPS, which are generally scheduled for non-emergency cases, began to return to normal levels as compared to the three months ended June 30, 2020, when procedures with CGuard EPS were mostly postponed as hospitals shifted resources to patients affected by COVID-19. This increase in sales of CGuard EPS was partially offset by a decrease of 54.8% in sales of MGuard Prime EPS from $42,000 during the three months ended June 30, 2020, to $19,000 during the three months ended June 30, 2021, largely driven by the predominant industry preferences favoring drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients.

For the three months ended June 30, 2021, gross profit (revenue less cost of revenues) increased by $382,000, to $262,000, from a gross loss of $120,000 during the three months ended June 30, 2020. This increase in gross profit resulted from a $237,000 increase in revenues less the related material and labor costs (as described above), a decrease in write-offs of $144,000, which were driven mainly by changes related to components supply issues and a decrease of $1,000 in miscellaneous expenses during the three months ended June 30, 2021. Gross margin (gross profits as a percentage of revenue) increased to 25.2% during the three months ended June 30, 2021 from (38.3)% during the three months ended June 30, 2020, driven mainly by the decrease in write-offs mentioned above.

Total operating expenses for the quarter ended June 30, 2021 were $3,702,000, an increase of 59.2% compared to $2,326,000 for the same period in 2020. This increase was primarily due to increases of $705,000 in salary expenses and related accrual expenses mainly driven by temporary salary reductions during the three months ended June 30, 2020, that were implemented in response to the COVID-19 effect on revenues as well as additional resources mainly in our product development and sales infrastructure, $437,000 in expenses related to the commencement of the C-Guardians FDA study, $315,000 in share-based compensation-related expenses due to the expense recognition of grants made after June 30, 2020, $297,000 in development expenses associated with CGuard EPS accessory solutions, and $108,000 of Directors’ and Officers’ Liability Insurance expense due to increased premiums caused by recent trends in the overall insurance industry. This increase was partially offset by a decrease of $400,000 relating to a settlement agreement with an underwriter of our prior offerings which occurred in the three months ended June 30, 2020 and a reduction of $86,000 of miscellaneous expense.

For the three months ended June 30, 2021, financial expenses were $67,000, compared to $34,000 during the three months ended June 30, 2020. Net loss for the second quarter of 2021 totaled $3,507,000, or $0.46 per basic and diluted share, compared to a net loss of $2,480,000, or $2.93 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 7,704,707 in Q2 2021 and 845,451 in Q2 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021.

Financial Results for the Six Months ended June 30, 2021

For the six months ended June 30, 2021, revenue increased by $697,000, or 51.7%, to $2,044,000, from $1,347,000 during the six months ended June 30, 2020. This increase was predominantly driven by a 60.0% increase in sales volume of CGuard EPS from $1,242,000 during the six months ended June 30, 2020, to $1,987,000 during the six months ended June 30, 2021. This sales increase was mainly due to the fact that in the six months ended June 30, 2021, procedures with CGuard EPS, which are generally scheduled for non-emergency procedures began to return to normal levels as compared to the six months ended June 30, 2020, when procedures with CGuard EPS were postponed as hospitals shifted resources to patients affected by COVID-19 beginning in February 2020. This increase in sales of CGuard EPS was partially offset by a decrease of 45.7% in sales of MGuard Prime EPS from $105,000 during the six months ended June 30, 2020, to $57,000 during the six months ended June 30, 2021, largely driven by the predominant industry preferences favoring drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in STEMI patients.

For the six months ended June 30, 2021, gross profit (revenue less cost of revenues) increased by $193,000, to $368,000, compared to a $175,000 for the same period in 2020. This increase in gross profit resulted from a $257,000 increase in revenues less the related material and labor costs (as described above). This increase was partially offset by an increase of $64,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 18.0% during the six months ended June 30, 2021 from 13.0% during the six months ended June 30, 2020, driven by the reasons mentioned above.

Total operating expenses for the six months ended June 30, 2021 were $7,122,000, an increase of 53.4% compared to $4,642,000 for the same period in 2020. This increase was primarily due to increases of $1,136,000 in salary expenses and related accrual expenses mainly driven by temporary salary reductions during the six months ended June 30, 2020, that were implemented in response to the COVID-19 effect on revenues as well as additional resources mainly in our product development and sales infrastructure, $563,000 in share-based compensation-related expenses due to the expense recognition of grants made after June 30, 2020, $521,000 in development expenses associated with CGuard EPS accessory solutions, $483,000 in expenses related to the commencement of the C-Guardians FDA study, $226,000 of Directors’ and Officers’ Liability Insurance expense due to increased premiums caused by recent trends in the overall insurance industry. This increase was partially offset by a decrease of $400,000 relating to a settlement agreement with an underwriter of our prior offerings which occurred in the three months ended June 30, 2020 and a reduction of $49,000 of miscellaneous expense.

For the six months ended June 30, 2021, financial income was $4,000, compared to $9,000 during the six months ended June 30, 2020. Net loss for the six months ended June 2021 totaled $6,750,000, or $0.98 per basic and diluted share, compared to a net loss of $4,458,000, or $7.73 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 6,918,090 for the six months ended June 2021 and 576,827 for the six months ended June 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021.

As of June 30, 2021, cash and cash equivalents were $41.4 million compared to $12.6 million as of December 31, 2020.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, August 10, 2021, to review financial results and provide an update on corporate developments.  Following management’s formal remarks, there will be a question-and-answer session.  

Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or unable to pre-register may dial in by calling: 1-844-854-4417 (domestic), or 1-412-317-5739 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the InspireMD call.

The conference call will also be available through a live webcast found here:  https://services.choruscall.com/mediaframe/webcast.html?webcastid=a2t5MXpf.

Additionally, it will be broadcast live through the Company’s website via the following link: https://www.inspiremd.com/en/investors/investor-relations/.

A webcast replay of the call will be available approximately one hour after the end of the call through November 10, 2021, at the above links. A telephonic replay of the call will be available through August 24, 2021, and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10158721.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.

InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR, and certain warrants are quoted on the Nasdaq under the symbol NSPRZ.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. For example, the company is using forward-looking statements when it discusses its future plans with respect to its CGuard EPS stent, its belief that its efforts has created potential future momentum for its CGuard EPS stent, the potential benefits of its listing on Nasdaq, the intends regulatory submission and commercial launch of its CGuard Prime and the belief that it has sufficient cash reserves and liquidity to fund its planned operations. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
[email protected]

CORE IR
[email protected]

CONSOLIDATED STATEMENTS OF OPERATIONS

(1)
 
(U.S. dollars in thousands, except per share data)  
      Six months ended  
  Three months ended    
June 30,   June 30,  
    2021       2020       2021       2020    
                 
                 
Revenues $ 1,038     $ 313     $ 2,044     $ 1,347    
Cost of revenues   776       433       1,676       1,172    
                 
Gross Profit   262       (120 )     368       175    
                 
Operating Expenses:                
Research and development   1,290       444       2,129       967    
Selling and marketing   636       377       1,344       1,001    
General and administrative   1,776       1,505       3,649       2,674    
                 
Total operating expenses   3,702       2,326       7,122       4,642    
                 
Loss from operations   (3,440 )     (2,446 )     (6,754 )     (4,467 )  
                 
Financial income (expenses)   (67 )     (34 )     4       9    
                 
Net Loss $ (3,507 )   $ (2,480 )   $ (6,750 )   $ (4,458 )  
                 
Net loss per share – basic and diluted $ (0.46 )   $ (2.93 )   $ (0.98 )   $ (7.73 )  
                 
Weighted average number of shares of
common stock used in computing net
loss per share – basic and diluted
  7,704,707       845,451       6,918,090       576,827    

CONSOLIDATED BALANCE SHEETS

(


2


)
(U.S. dollars in thousands)
ASSETS

June 30,   December 31,
2021   2020
       
Current Assets:      
Cash and cash equivalents $ 41,419   $ 12,645
Accounts receivable:      
Trade, net   962     476
Other   136     146
Prepaid expenses   63     334
Inventory   1,342     1,415
Receivable for sale of Shares       323
       
Total current assets   43,922     15,339
       
       
Non-current assets:  
Property, plant and equipment, net   443     448
Operating lease right of use assets   1,251     1,265
Funds in respect of employee rights upon retirement   759     725
       
Total non-current assets   2,453     2,438
       
Total assets $ 46,375   $ 17,777

LIABILITIES AND EQUITY

June 30,   December 31,
2021   2020
       
Current liabilities:      
Accounts payable and accruals:      
Trade $ 739     $ 236  
Other   2,940       3,469  
       
Total current liabilities   3,679       3,705  
       
Long-term liabilities:      
Operating lease liabilities   904       999  
Liability for employees rights upon retirement   962       910  
Total long-term liabilities   1,866       1,909  
       
Total liabilities   5,545       5,614  
       
Equity:      
Common stock, par value $0.0001 per share; 150,000,000
shares authorized at June 30, 2021 and December 31, 2020;
7,914,339 and 3,284,322 shares issued and outstanding at
June 30, 2021 and December 31, 2020, respectively
  1     *  
Preferred B shares, par value $0.0001 per share;
500,000 shares authorized at June 30, 2021 and December 31,
2020; 0 and 17,303 shares issued and outstanding at June 30,
2021 and December 31, 2020
      *  
Preferred C shares, par value $0.0001 per share;
1,172,000 shares authorized at June 30, 2021 and December 31,
2020; 1,718 and 2,343 shares issued and outstanding at June 30,
2021 and December 31, 2020, respectively
  *     *  
Additional paid-in capital   215,755       180,339  
Accumulated deficit   (174,926 )     (168,176 )
       
Total equity   40,830       12,163  
       
Total liabilities and equity $ 46,375     $ 17,777  
       

(1) All 2021 financial information is derived from the Company’s 2021 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2020 financial information is derived from the Company’s 2020 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All June 30, 2021 financial information is derived from the Company’s 2021 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2020 financial information is derived from the Company’s 2020 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2020 filed with the Securities and Exchange Commission.



Finch Therapeutics Announces Takeda to Accelerate Leadership Role in FIN-524 Ulcerative Colitis Development Program

  • Finch to transfer FIN-524 program to Takeda for clinical development
  • Finch and Takeda to continue discovery efforts targeting Crohn’s disease

SOMERVILLE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) — Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced that Takeda Pharmaceutical Company Limited (“Takeda”) has elected to accelerate the transition of development responsibility for the FIN-524 ulcerative colitis development program. Takeda will assume primary development responsibility for the program, now known as TAK-524, ahead of the planned initiation of clinical-stage development. The transition will enable Takeda to leverage its expertise in inflammatory bowel disease (IBD) throughout the clinical development of FIN-524/TAK-524.

“Microbiome research is an important pillar of our drug discovery strategy as we continue to invest in novel approaches to treat chronic GI disorders,” said Gareth Hicks, PhD, Vice President & Head of Gastroenterology Drug Discovery Unit at Takeda. “Through our successful collaboration with our expert partners Finch, TAK-524 is now poised to become Takeda’s third clinical-stage program leveraging state-of-the-art approaches to intervene in the gut microbiome for the treatment of GI disease.”

“We are thrilled that Takeda, a global leader in the treatment of IBD, has opted to accelerate its role in advancing TAK-524 for ulcerative colitis. We believe that Takeda’s leadership and experience in IBD will be a critical asset for the program as Takeda prepares to advance TAK-524 into clinical development,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “We look forward to continuing our collaboration with Takeda to support the TAK-524 program along with our joint discovery work in Crohn’s disease, while we continue to advance other exciting programs in our pipeline.”

FIN-524/TAK-524 is an investigational, orally administered targeted consortia product candidate composed of both spore-forming and non-spore-forming bacterial strains selected for the treatment of ulcerative colitis. FIN-524/TAK-524 is designed to treat ulcerative colitis by harnessing the gut microbiome’s ability to modulate the host immune system.

About the Collaboration and License Agreement

In 2017, Finch entered into a worldwide collaboration agreement with Takeda to jointly develop FIN-524/TAK-524 for the treatment of inflammatory bowel disease. Under the terms of the agreement, Finch received an upfront payment of $10 million from Takeda for the exclusive worldwide rights to develop and commercialize FIN-524/TAK-524. Finch has received $4 million in milestone payments to date for FIN-524/TAK-524 and is eligible to receive up to an additional $176 million in payments upon achievement of certain development, regulatory, and commercial milestones, as well as tiered royalties ranging from mid to high-single digits on worldwide net sales of FIN-524/TAK-524. Under the terms of the original agreement, Finch was primarily responsible for early-stage development activities through Phase 2 clinical trials. Under the terms of an amended agreement executed in August 2021, Takeda will assume primary development responsibility for FIN-524/TAK-524 prior to the start of clinical-stage development. After the transition, Finch plans to provide Takeda with ongoing technical support through the anticipated Phase 1 trial of FIN-524/TAK-524 in ulcerative colitis.

About FIN-524/TAK-524 for Ulcerative Colitis

FIN-524/TAK-524 is an investigational, orally administered targeted consortia product candidate composed of both spore-forming and non-spore-forming bacterial strains selected for the treatment of ulcerative colitis. The consortia is designed to include strains that target multiple defined mechanisms of action combined with donor strains linked to remission following fecal microbiota transplantation (FMT) in patients with ulcerative colitis. The design of FIN-524/TAK-524 leverages Finch’s machine-learning based platform and data from FMT studies in ulcerative colitis. Machine learning was used to identify microbes and microbial functions deficient in patients with ulcerative colitis. Human FMT data was leveraged to identify organisms consistently enriched in ulcerative colitis patients that successfully responded to FMT. Target organisms were isolated directly from the specific donors whose samples induced response or remission in clinical studies of FMT for ulcerative colitis. The manufacture of FIN-524/TAK-524 is donor independent, with the strains grown from master cell banks.

About Ulcerative Colitis

Ulcerative colitis is one of the most common types of inflammatory bowel disease (IBD), an autoimmune condition that causes inflammation of the gastrointestinal (GI) tract. Approximately 10 million people are affected by IBD worldwide, including about three million people in the US. Symptoms of IBD include severe, chronic abdominal pain, diarrhea, GI bleeding, weight loss, and fatigue. Current treatment options are ineffective for many people with IBD.

About Finch Therapeutics


Finch Therapeutics
is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI), and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. PRISM4, a Phase 3 trial, is designed to serve as the second pivotal trial of CP101 for recurrent CDI. Finch is also developing CP101 for the treatment of chronic hepatitis B virus, and FIN-211 for the treatment of the gastrointestinal and behavioral symptoms of autism spectrum disorder. Finch has a partnership with Takeda focused on the development of targeted microbiome therapeutics for inflammatory bowel disease.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” “projects,” “would” and “future” or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding: Finch’s ability to advance the development of a novel class of therapeutics, including with respect to FIN-524/TAK-524; the therapeutic value and development of FIN-524/TAK-524 for the treatment of ulcerative colitis, including Takeda’s ability and timing to initiate clinical trials; the results of the Collaboration and License Agreement; Finch’s pipeline and ability to develop additional product candidates; and the initiation and timing of Finch’s clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Finch’s limited operating history and historical losses; Finch’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Finch’s dependence on the success of its lead product candidate, CP101; the possibility that Finch or Takeda may be delayed in initiating, enrolling or completing any clinical trials; results of clinical trials may not be sufficient to satisfy regulatory authorities to approve product candidates in their targeted or other indications (or such authorities may request additional trials or additional information); results of clinical trials may not be indicative of final or future results from later stage or larger clinical trials (or in broader patient populations once the product is approved for use by regulatory agencies) or may not be favorable or may not support further development; Finch’s product candidates, including FIN-524/TAK-524, may not generate the benefits to patients that are anticipated; anticipated regulatory approvals may be delayed or refused; competition from third parties that are developing products for similar uses; Finch and Takeda’s ability to maintain patent and other intellectual property protection and the possibility that Finch or Takeda’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finch’s ability to qualify and scale its manufacturing capabilities in anticipation of commencement of multiple global clinical trials; Finch’s lack of experience in selling, marketing and distributing its product candidates; Finch’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact and duration of the COVID-19 pandemic on Finch’s business. These and other risks are described more fully in Finch’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in Finch’s Quarterly Report on Form 10-Q filed with the SEC on May 13, 2021, as well as discussions of potential risks, uncertainties, and other important factors in Finch’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Finch undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc.

Media Contact:

Jenna Urban
Berry & Company Public Relations
[email protected]
212-253-8881

Investor Contact:

Laurence Watts
Gilmartin Group
(619) 916-7620
[email protected]

or

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]